Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
Healthy Volunteers
NCT05473793

Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

Led by Wageningen University · Updated on 2025-02-25

160

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

W

Wageningen University

Lead Sponsor

W

WholeFiber BV

Collaborating Sponsor

AI-Summary

What this Trial Is About

A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.

CONDITIONS

Official Title

Impact of a Dried Vegetable on Bowel Function and Gut Microbiota

Who Can Participate

Age: 20Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 20 and 80 years
  • Self-reported dissatisfaction with bowel function rated less than 6 on a 0-10 scale
  • Four or fewer bowel movements per week and/or hard, lumpy or solid stools during 90% of bowel movements
  • Able to read and understand Dutch or English
Not Eligible

You will not qualify if you...

  • History of medical or surgical conditions affecting bowel function, including IBS, IBD, or medically diagnosed constipation
  • Less than one bowel movement per week during screening
  • Antibiotic use within 3 months prior to screening
  • Chronic use of antacids or proton pump inhibitors
  • Use of laxatives during screening
  • Chronic use of blood glucose lowering medication
  • Use of fiber supplements, pro-/post-/synbiotics within 1 month before screening
  • Unwillingness to provide fecal samples or comply with study procedures
  • Current or planned pregnancy or lactation for women of childbearing age
  • Known allergies to plants in the Asteraceae family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory)
  • Unexplained weight change greater than 5 kg in the month before screening
  • Following slimming or medically prescribed diets
  • Macrobiotic lifestyle
  • Employment in the Division of Human Nutrition & Health or the Laboratory of Microbiology
  • Current participation in other medical research
  • No general practitioner
  • Unwillingness to be informed about accidental health discoveries

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wageningen University & Research, Division of Human Nutrition & Health

Wageningen, Gelderland, Netherlands, 6708 WE

Actively Recruiting

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Research Team

E

Edith JM Feskens, Prof. dr

CONTACT

S

Sofie CC van der Zalm, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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